The European Union has recognised the importance - and potential - of mobile heath, or mHealth, and in 2014, developed a Green Paper on mHealth. mHealth is said to cover “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistances (PDAs), and other wireless devices”. The uses of such applications, or apps, are infinite, and could range from appointment reminders, to reference or educational materials for healthcare professionals or patients, to monitoring and recording of a number of variables about the user, to diagnostic tools.

The Green Paper identified the many overlapping technical, regulatory, legal, and public policy issues that have an impact on the development of mHealth technology. With the rapid development in this area, in particular with respect to apps to help healthcare professionals and patients, it is important that apps meet certain core guiding principles relevant to their design and testing so that their characteristics and performance meet an acceptable level of safety.

Responses to the Green Paper have resulted in the European Commission appointing a Working Group to progress the development of common EU guidelines on the development of mHealth apps and to provide a common assessment methodology. The first draft of the “Guidelines for assessing the validity and reliability of mHealth apps data” was published on 25 April 2016 (the Guidelines), and on 4 May 2016, the Guidelines were discussed in an open stakeholder meeting.

Purpose of the Guidelines

During consultations with stakeholders in 2015, a “common understanding” of the various health risks associated with the development of mHealth apps was developed, particularly with regard to:

  • clinical evidence;
  • claims about the purpose and functions of mHealth apps; and
  • testing and validation of the performance of apps.

The Guidelines, therefore, aim to establish a common set of criteria relating to quality, safety, reliability, and effectiveness to underpin the methodologies that can be used for assessing health apps. While the Guidelines, when adopted, will be voluntary, they are nonetheless important to guide good practice in developing mobile health apps, and to instill confidence among healthcare professionals so apps can be used as an integral part of the treatment pathway.

The draft Guidelines focus on the safety and utility evaluation, and an assessment of the efficacy of such apps is being considered separately, along with details of the risk assessment discussed below. It is contemplated that all these aspects will ultimately be consolidated into a single guidance document. However, much of the operation of the Guidelines is unclear at this time, and the practical impact is dependent on a number of other factors.

Structure of the Guidelines

The Guidelines divide the evaluation of an mHealth app into three phases:

1. Initial validation

This forms the initial assessment of the app platform taking account relevant data in respect of its:

  • properties;
  • functionality;
  • mode of use; and
  • intended purpose.

The initial assessment of the performance and characteristics of the app will inform the down-stream risk assessment in relation to the impact of the app on the health and safety of patients.

2. Risk assessment

This phase seeks to assess the potential risk of the app to determine the level of scrutiny required, and drive the degree to which the answers to the scrutiny assessment are considered relevant. The assessment determines the harm that may be posed to patients arising from the complexity, functionality and potential misuse of the app. The current proposal is for low risk apps to be assessed via a self-assessment system, whereas apps with increased levels of risk will require more involvement of third parties, including regulatory bodies, to validate the assessment.

The risk-based approach is consistent with that already adopted in the European Medical Devices Directive 93/42/EEC for the purpose of classifying a medical device and to inform the procedures to be followed in respect of its conformity assessment, and is likely to be familiar to most app developers in this field.

The detailed guidance on the risk assessment is currently the subject of a separate discussion.

3. Scrutiny

This part of the Guidelines sets out a series of questions, taking account the technology platform and the medical aspects of the app, which ought to be considered when assessing an app in order to verify its:

  • usability;
  • credibility;
  • reliability;
  • stability;
  • safety; and
  • compliance with personal data security requirements.

The Guidelines propose a number of methods for assessing an app, including allocating a score for each question weighted based on the risk, having a simple pass/fail outcome based on the responses to the questions, or a certification scheme by a third party, similar to the evaluation of high-risk medical devices. Alternatively, the list of questions could simply be used by third parties when commissioning or acquiring an app to inform an assessment of its “value” or “position” in the market.

The questions are wide ranging, and some may not be adopted following the public consultation, particularly when considering whether they are critical to an evaluation of an app’s impact on the safety, integrity, and privacy of patients. For example, whether the colour coding is aesthetically pleasing, and whether the visual icons make the app attractive may not be viewed as crucial. In contrast, other questions may be considered as particularly impactful as regards the objective assessment of the applicability, inter-operability, validity and reliability of the app, and may be highly relevant to a determination of the safe and effective use of the app in a given patient population. For example, whether the app has been validated by an appropriate group of specialised professionals, health organisations or scientific society may be a relevant consideration to determine the credibility of the app for the intended purpose.

Interface with medical devices

The Green Paper and draft Guidelines both state that they do not cover apps that are classified as medical devices, as they will be regulated in accordance with the Medical Devices Directive. However, the Guidelines list a number of categories of apps that will be covered, which includes categories that could, in certain situations, be classified as medical devices, such as “clinical decision support tools for diagnosis/treatment recommendations” and “point-of-care diagnosis, monitoring or treatment aids”. The line between medical devices and wellbeing apps is blurred and subject to a certain amount of subjective interpretation by the regulatory authorities. The Guidelines acknowledge this grey area, and state that “the criteria for those apps that are on the borderline and could fall under the medical device definition could be aligned with the medical devices requirements as far as possible”, and that where an app has the potential to create a hazardous situation, it should be treated in a similar way to medical devices. This is an area that will need to be clarified in later versions of the Guidelines.

Next Steps

The Guidelines are now being consulted on with a range of stakeholders; the deadline for providing input is 16 May 2016. Feedback from the consultation will lead to further development of the Guidelines, and at least three more drafts are anticipated. A final version of the Guidelines is expected by the end of 2016.